MAUDE Adverse Event Report: MICROBLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	MICBLNDR,.15-1.0/2-16 LPM,DISS,CE,LO
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that the microblender had a malfunction.As of this time, there is no information about patient involvement associated with this reported event.

• Brand Name: MICROBLENDER
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• MDR Report Key: 12685932
• Report Number: 2021710-2021-14763
• Device Sequence Number: 11103618
• Product Code: BZR
• UDI-Device Identifier: 10846446002225
• UDI-Public: (01)10846446002225(11)20200101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K883038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MICBLNDR,.15-1.0/2-16 LPM,DISS,CE,LO
• Device Catalogue Number: 10040A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1